Treatment With Autologous Skeletal Myoblasts

Phase II, Randomised, Controlled Study of Treatment With Revascularisation Surgery With or Without Injection of Autologous Skeletal Myoblasts in Patients With Old Myocardial Infarction

The purpose of this study is to determine the benefit of autologous skeletal myoblast injection in patients with old myocardial infarction and ventricular dysfunction versus conventional revascularisation therapy.

Study Overview

• Status: Terminated
• Conditions: Old Myocardial Infarction
• Intervention / Treatment: Procedure: Intra-lesion injection of autologous skeletal myoblasts; Procedure: Revascularisation

Detailed Description

Ischaemic heart disease is one of the main causes of mortality and morbidity. In particular, myocardial infarction (MI) is of special significance, as the heart muscle cannot regenerate so a region's necrosis leads to the formation of a fibrous scar. Depending on the area affected by the scar, infarction can lead to a progressive and irreversible decline in cardiac function, giving way to heart failure (HF) syndrome. The molecular basis of congestive heart failure is the absence of cardiac stem cells capable of regenerating cardiac muscle. In the skeletal muscle, there are cells located beneath the basal membrane with are capable of regenerating muscle fibres; they are known as myoblasts. There are several studies with autologous myoblasts, either by direct administration during surgery or percutaneously, which could distinguish between the effect of revascularisation surgery and that of the myoblast injection. The objective of this study is compare improvement in global and regional cardiac function in patients with old MI obtained by aortocoronary bypass surgery with intracardiac administration of autologous skeletal myoblasts versus standard aortocoronary bypass surgery treatment.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28007
    • Hospital Gregorio Marañón
  • Salamanca, Spain, 37007
    • Hospital Clínico Universitario de Salamanca
  • Valencia, Spain, 46009
    • Hospital la Fé
  • Galicia
    • Santiago de Compostela, Galicia, Spain, 15706
      • Hospital Clínico Universitario de Santiago
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Clinica Universitaria de Navarra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with a diagnosis of coronary disease obtained by coronary angiography who require conventional aortocoronary bypass surgery.
• History of myocardial infarction with evidence of regional akinesis (or dyskinesia) for more than 4 weeks and less than 10 years.
• Ejection fraction from 25% to 45%.
• Evidence of no regional viability by dobutamine echocardiography.
• Aged from 30-80 years old.
• Negative serology to HIV, HBV and HCV.
• Patients without organ dysfunction.
• Negative pregnancy test (women of childbearing age).
• Informed consent granted.

Exclusion Criteria:

• History of myocardial infarction in the 4 weeks prior to the inclusion in the study.
• Prior history of tachycardia or ventricular fibrillation (except in patients with DAI device).
• History of cancer (except basocellular carcinoma) or prior treatment with chemotherapy.
• The patient should not suffer from any concomitant severe and/or uncontrolled medical condition.
• Patients who, due to their geographical, psychiatric or social status, have difficulties in meeting the conditions established in the protocol.
• Pregnant or beast feeding women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Skeletal myoblasts; Patients who are receiving skeletal myoblasts	Procedure: Intra-lesion injection of autologous skeletal myoblasts; Intra-lesion injection; Procedure: Revascularisation; Revascularisation surgery
Placebo Comparator: Placebo; Revascularisation surgery	Procedure: Revascularisation; Revascularisation surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary efficacy endpoints will be evaluate the ejection fraction and wall motion score index measured by M-mode and echocardiography 12 months after surgery.	12 months after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Secondary efficacy endpoints are viability, perfusion and thickening and incidence of cardiac arrhythmias.	12 month after surgery

Collaborators and Investigators

• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra
• Collaborators: Fina Biotech
• Investigators: Study Director: Felipe Prosper, MD, PhD, Clinica Universidad de Navarra

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: September 10, 2009
• First Submitted That Met QC Criteria: September 10, 2009
• First Posted (Estimate): September 11, 2009

Study Record Updates

• Last Update Posted (Estimate): June 8, 2012
• Last Update Submitted That Met QC Criteria: June 7, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Intra-lesion injection of autologous myoblasts
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: Mio/Reg/Quirur/Aleatorizado